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Topical Bimatoprost for Chemical Blepharoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830776
Recruitment Status : Unknown
Verified April 2017 by Megan Couvillion, Tulane University.
Recruitment status was:  Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Megan Couvillion, Tulane University

Tracking Information
First Submitted Date  ICMJE July 7, 2016
First Posted Date  ICMJE July 13, 2016
Last Update Posted Date May 2, 2017
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2016)
Graded improvement in dermatochalasis [ Time Frame: Weeks 0, 4, 8, 12 ]
Patients will be followed Q 4 weeks in clinic with followup photodocumentation at each visit for a total of 4 visits, 3 months of treatment. At completion of the study period, each patient's photographs at weeks 0, 4, 8, and 12, will be graded by 2 blinded evaluators for level of dermatochalasis: -1 (deep upper eyelid sulcus), 0 (no dermatochalasis), 1 (mild, slightly noticeable), 2 (moderate, noticeable), or 3 (severe, distinctive).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2016)
Improved patient satisfaction [ Time Frame: Weeks 0, 12 ]
Entry and exit surveys will be completed about self perception of the periocular area
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Bimatoprost for Chemical Blepharoplasty
Official Title  ICMJE Topical Bimatoprost for Chemical Blepharoplasty
Brief Summary

Topical bimatoprost has been shown to cause periorbital changes of soft tissue which are most pronounced when used directly onto the cornea for the treatment of glaucoma. Changes are primarily felt to be the result of prostaglandin-mediated adipocyte loss, resulting in deepening of the upper eyelid sulcus and recession of infraorbital pseudoherniation. Use of topical bimatoprost to the upper eyelid margin, now FDA approved for eyelash enhancement, may provide a metered effect on the periocular tissues and allow for a topical approach to periocular rejuvenation.

This is a proof of concept study which aims to enroll a series of patients with mild to severe dermatochalasis, treat with topical bimatoprost 0.03% solution to the upper lid margin, and evaluate for cosmetic improvement of the periocular area.

Detailed Description

Perception of beauty in the periocular region is influenced by several factors, including symmetry, population norms, and skin texture and tone. Soft tissue and skin changes over time create an aged appearance with the development of dermatochalasis, blepharoptosis, lacrimal gland prolapse, and fat prolapse. Techniques for periocular rejuvenation are well established and include soft tissue augmentation, resurfacing, and surgical correction. In May 2015, Sarnoff and Gotkin reported a case of "chemical blepharoplasty" achieved with topical bimatoprost ophthalmic 0.03% solution applied to the upper eyelid margin. After three months of use, the author noted a more youthful appearance of the periocular region, with deepening of the upper eyelid sulcus, reduction in dermatochalasis, and diminution of the inferior eyelid fat pad. These changes were attributed to the prostaglandin associated periorbitopathy (PAP), a well described phenomenon observed with the use of topical prostaglandin analogues use for glaucoma.

Periorbital changes observed with topical prostaglandin analogues are primarily due to effects on aponeurotic and deep orbital adipocytes. Prostaglandins activate the adipocyte mitogen-activated protein kinase (MAPK) pathway, leading to inactivation of peroxisome proliferator-activated receptor (PPAR)-gamma, inhibition of adipocyte differentiation, and decreased fat accumulation within adipocytes. Bimatoprost concentration-dependent contractions of ciliary muscles and activation of matrix metalloproteinases may also contribute to periocular changes. Patients using topical ophthalmic prostaglandin analogues commonly develop periorbital fat loss, which has been well characterized in the ophthalmology literature.

Bimatoprost applied to the upper eyelid margin for eyelash enhancement attempts to capitalize on the desirable effects of darker, longer, thicker eyelashes, while limiting more significant and undesirable effects through limited exposure of the drug to ocular tissues. This same concept may apply for dermatochalasis: at a metered dose, topical bimatoprost to the lid margin could lead to subtle periorbital fat loss resulting in improved dermatochalasis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dermatochalasis
Intervention  ICMJE Drug: bimatoprost 0.03% ophthalmic solution
Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
Other Name: Latisse
Study Arms  ICMJE Experimental: Treatment group
This is a single-arm open label proof of concept pilot study evaluating use of Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping).
Intervention: Drug: bimatoprost 0.03% ophthalmic solution
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 30, 2017)
14
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2016)
15
Estimated Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18+,
  • mild to severe dermatochalasis, desire for enhanced eyelashes.

Exclusion Criteria:

  • Patients with current use of ophthalmic prostaglandin analogues,
  • history of blepharoplasty,
  • history of neuromodulators or fillers to the periocular region or frontalis in the last 6 months,
  • existing deep upper eyelid sulcus,
  • opposition to eyelash enhancement,
  • pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02830776
Other Study ID Numbers  ICMJE 833277-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Megan Couvillion, Tulane University
Study Sponsor  ICMJE Tulane University
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Megan P Couvillion, MD, MS Tulane University School of Medicine, Department of Dermatology
PRS Account Tulane University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP